Assessing How Normal Variations in CT Scanning Affects Its Interpretation

Colorectal Cancer Metastatic Clinical Trial

Official title:

Stability of Radiomic Features for Abdominal Tumors on Contrast Enhanced CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03038568
• Other study ID #: 17-010
• Status: Recruiting
• Start date: January 27, 2017
• Est. completion date: January 27, 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kinh Gian Richard Do, MD, PhD
• Phone: 212-639-8591
• Email: dok[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to see how measurements of tumor differences vary with slight changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even in the setting of variable scan parameters and variable contrast timing. Participants will be consented to undergo an additional CT of their abdomen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age on the day of signed informed consent
• Patients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocol as per local institutional guidelines
• Patients with measurable colorectal liver metastases on prior imaging, with at least one tumor greater than 2.0 cm in axial maximal diameter

Exclusion Criteria:

• Patient who is pregnant and/or lactating
• Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. Triple Phase or Quadruple Phase Liver CT)
• Patient who require reduced intravenous contrast dose based on the Department of Radiology contrast policy as per local institutional guidelines
• Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• CT scan
Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center, Texas (Data collection only)	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Queen's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans	There will be 18 cohorts, each cohort differing by the length of the time gap in acquisition and noise index. In addition each acquisition will be reconstructed in 21 different ways (combinations of 3 slice thicknesses and 7 ASiR levels).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center